Dose-Response in Radioimmunotherapy of Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Dose-Response in Radioimmunotherapy of Lymphoma
OBJECTIVES:
Primary
- Determine the relationship between estimated absorbed dose and tumor response using
different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with
iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.
- Determine the relationship between estimated absorbed dose and normal organ toxicity
using different dosimetric methodologies in these patients.
Secondary
- Assess the difference in the dose-response relationship between dosimetric
methodologies in these patients.
- Assess the influence of prior therapy on the dose-response relationship for hematologic
toxicity in these patients.
OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I
131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).
- Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In)
ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission
tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT
scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan
administration. Patients who have acceptable biodistribution receive therapeutic
rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between
days 7-9.
- Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by
iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT
scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable
biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I
tositumomab IV over 20 minutes on approximately day 7.
In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also
undergo a baseline PET/CT scan.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of non-Hodgkin's lymphoma
- Measurable disease by CT scan or nuclear medicine imaging
- Eligible, by standard of care criteria, for iodine I 131 tositumomab or yttrium Y 90
ibritumomab tiuxetan treatment
PATIENT CHARACTERISTICS:
- No other malignancy within the past 3 years except basal cell carcinoma or squamous
cell carcinoma of the skin or in situ carcinoma of the cervix
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No alcoholism or drug abuse within the past 2 years
- No severe emotional, behavioral, or psychiatric problems that would limit study
compliance
PRIOR CONCURRENT THERAPY:
- No concurrent participation in another investigational drug study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relationship between estimated absorbed dose and tumor response using different dosimetric methodologies
Outcome Time Frame:
July '06 to Sept '10
Safety Issue:
No
Principal Investigator
George Sgouros, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
JHOC-J0636
NCT ID:
NCT00416312
Start Date:
July 2006
Completion Date:
October 2009
Related Keywords:
- Lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- splenic marginal zone lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- Waldenström macroglobulinemia
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- adult grade III lymphomatoid granulomatosis
- recurrent adult grade III lymphomatoid granulomatosis
- primary central nervous system non-Hodgkin lymphoma
- adult nasal type extranodal NK/T-cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
